The main functionality of the AU eCTD Compiler is the creation of valid TGA electronic dossier submissions along with the lifecycle management.

By using the AU eCTD Compiler and its change control process, several topics including regional-aware approved template, lifecycle management, attributes, granularity, and envelope values are addressed and solved.

Built in validation supporting regional rules ensures no invalid submissions can be generated.

Regularly updated following the changes in the TGA / ICH eCTD specification.

Envelope elements creation

Import / export files from SharePoint / Documentum.

Share / collaborate your eCTD compilations.

Submit faster in teams - merge compilation from your team members.

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Create pCTD from eCTD

Quick conversion of an electronic submission to paper.

New Zealand NeeS

Convert TGA, FDA, Health Canada, EMA and MHRA dossiers to the format required by Medsafe with minimal additional manipulation. All dossiers published using eCTD Office are fully hyperlinked and bookmarked to the Table of Contents that is generated, facilitating navigation and evaluation at Medsafe.

Medsafe New Medicine Applications

Customised templates for compilation and publishing of NMAs for evaluation under either the non-abbreviated process or the extended abbreviated process can be generated quickly and easily.